BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELECT XT 2CH STIM

    MDR report key: 1444517 · Received August 18, 2009

    Report

    Report Number
    1022819-2009-00175
    Event Type
    Injury
    Date Received
    August 18, 2009
    Report Date
    July 8, 2009
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IPF
    PMA / PMN Number
    K040285
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS REPORTED INSTANCES OF ADVERSE EVENTS (MFG REPORT NUMBERS: 1022819-2009-00173, 1022819-2009-00174, 1022819-2009-00175) WITH 3 SEPARATE DEVICES, BUT IS UNAWARE OF ANY DETAILS REGARDING THE INCIDENTS. SEVEN INVESTIGATIONAL INQUIRIES HAVE BEEN UNABLE TO DETERMINE TREATMENT PARAMETERS, PT PREPARATION FOR TREATMENTS, OR ANY OTHER PERTINENT PT INFO. THERAPIST IS UNWILLING OR UNABLE TO DISCLOSE ANY INFO REGARDING THE EVENTS. ALL REPORTS TO CHATTANOOGA GROUP OCCURRED ON SAME DAY. CHATTANOOGA GROUP ENGINEERING DEPT HAS EVALUATED THIS DEVICE. DEVICE PASSED ALL TESTS PERFORMED. EVAL WAS PERFORMED USING OSCILLOSCOPE TO VERIFY OUTPUT PARAMETERS. PARAMETERS WERE WITHIN MFR SPECIFICATION.

    Description of Event or Problem · 1

    THERAPIST REPORTS THAT A MALE PT WAS BEING TREATED ON ANKLE WHEN INCIDENT OCCURRED. TREATMENT DATE WAS UNK BY THERAPIST. RED, BOIL-LIKE BURN OCCURRED DURING TREATMENT UNDER ELECTRODE. TREATMENT WAS INTERRUPTED. THERAPIST WAS UNAWARE AS TO WHETHER OR NOT THE PT SOUGHT MEDICAL TREATMENT FOR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELECT XT 2CH STIM IPF, GZJ, GZI IPF CHATTANOOGA GROUP 2763

    Patients

    Seq Age Sex Outcome Treatment
    1